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Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

Innovasis, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251073
Device name
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-04-08
Decision date
2025-07-23
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Intended Use

The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.

Summary parsed at:2026-06-19 05:22:11 UTC

Predicate devices

4

K251073 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251073 as a predicate